FDA Speeds Lymph Node Detector Review for Head/Neck Cancer

(Navidea Biopharmaceuticals Inc.)

18 February 2014.  Navidea Biopharmaceuticals Inc. in Dublin, Ohio, says the U.S. Food and Drug Administration is giving the company’s diagnostic agent Lymphoseek priority review for detecting the spread of head and neck cancers to lymph nodes. FDA granted the accelerated review as part of its acceptance of Navidea’s supplemental new drug application to expand the coverage of Lymphoseek from its currently approved scope of breast cancer and melanoma.

Lymphoseek detects the spread of cancer from the initial tumor to the lymph nodes, the organs in the body that collect lymph fluids for the transfer of glucose, oxygen, and nutrients to cells, as well as disposal of waste products from bacteria and viruses. Lymph nodes are also part of the immune system, where B- and T-type lymphocytes reside that monitor lymph fluids for invaders and activate an immune response.

Since many types of cancer spread through the lymph system, detecting cancer in the lymph nodes is an early indicator that a cancer is spreading. Lymphoseek targets receptors in sentinel lymph nodes, the first lymph nodes where a cancer spreads, with a radioactive compound that binds to these receptors and illuminate lymph nodes with cancer in diagnostic imaging. The company says Lymphoseek makes it possible to identify cancerous sentinel lymph nodes in as little as 10 minutes, and for as long as 30 hours.

Navidea tested Lymphoseek in a late-stage clinical trial, results of which were provided to FDA as part of the company’s supplemental new drug application. The trial enrolled some 80 patients with squamous cell carcinoma, a form of skin cancer, on their heads or necks, and of those patients, 39 were also found with cancer in their lymph nodes, indicating the cancer had started spreading. Those 39 patients were given injections of Lymphoseek.

Radiological imaging of the 39 patients given Lymphoseek accurately identified the cancerous sentinel lymph nodes in all but one of the cases, giving a false negative rate of 2.6 percent, below the predefined threshold of unacceptable performance. In addition, the use of Lymphoseek sharply reduced the need for surgical removal of lymph nodes for biopsies on or near the heads and necks of patients. Of the total patients in the clinical trial, an average of 38 lymph nodes per patient were removed for biopsies, while for those receiving Lymphoseek, only four lymph nodes were removed per patient.

Priority review is one of FDA’s procedures to accelerate the review process of new drugs. The agency grants priority review for new drugs that show increased effectiveness in treating or diagnosing a disorder, sharply reduce adverse reactions to drugs, improve patients compliance with treatments or diagnostics,or  expand safety or effectiveness to more types of patients.

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